DEVICE: OPTIGUIDE® DCYL Cylindrical Diffuser (00376128000063)
Device Identifier (DI) Information
OPTIGUIDE® DCYL Cylindrical Diffuser
740
In Commercial Distribution
Pinnacle Biologics, Inc.
740
In Commercial Distribution
Pinnacle Biologics, Inc.
The DYCL series OPTIGUIDE® Fiber Optic Diffuser is a light delivery system consisting of a 400 μm coated silica laser fiber, a proximal SMA-type laser connector, and a distal light diffusing tip (1.07mm diameter).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Laser beam delivery unit, fibreoptic | A flexible fibreoptic cable intended to be used for the delivery of laser energy of visible and near-infrared wavelengths. It permits the transmission of the laser's output to the target site vicinity. A disposable laser fibre contact probe can be coupled to this for final delivery of the laser beam to the target site. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
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MVG | System, Laser, Fiber Optic, Photodynamic Therapy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P940010 | 011 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 4.0 Centimeter |
Device Record Status
ab5ee121-09fd-4eb5-962e-8d926043c591
July 06, 2018
3
September 16, 2014
July 06, 2018
3
September 16, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-866-248-2039
pinnaclemedinfo@optum.com
pinnaclemedinfo@optum.com